FDA UDI
In Commercial Distribution
🇺🇸 United States
Sys*Stim 240
DI: 00816864020166
·
Model: ME 240
·
METTLER ELECTRONICS CORP.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sys*Stim 240
- Primary DI
- 00816864020166
- Version / Model
- ME 240
- Catalog Number
- ME 240
- Company Name
- METTLER ELECTRONICS CORP.
- Labeler DUNS
- 008513913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 4
- Public Version Date
- 2019-05-23
- Public Version Status
- Update
- Public Device Record Key
- c8c8df3d-4d49-4651-b56c-765c55ac6bf9
Device Description
Neuromuscular stimulator features 9 discrete waveforms (2-channel stim with optional laser)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILY | Lamp, infrared, therapeutic heating | Physical Medicine | 890.5500 | 2 |
| GZJ | STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF | Neurology | 882.5890 | 2 |
| IPF | Stimulator, muscle, powered | Physical Medicine | 890.5850 | 2 |
| LIH | INTERFERENTIAL CURRENT THERAPY | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46571 | Physical therapy transcutaneous electrical stimulation system, line-powered | An assembly of mains electricity (AC-powered) devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical calf muscle stimulation to prevent venous thrombosis, and/or to maintain or increase range of motion. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816864020166 | GS1 |
Customer Contacts
- Phone
- +1(714)533-2221 ext. 319
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113017 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 5.5 pounds with battery | ||
| Weight | 4.5 | Pound |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Operating Temperture: 50-104 F
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 167 Degrees Fahrenheit